Older Patients & Studies

Older Patients & Clinical Studies

If you are an older patient, you may think clinical studies, also called clinical trials, are not for you simply because of your age. But this is not necessarily the case. Older people have different levels of health and independence and different expectations of treatment. In many cases a person’s age need not be a major factor in determining their treatment options for cancer or another serious disease.

Historically, older patients have been underrepresented in clinical studies. But the trend is improving.

“Attitudes toward enrolling older patients in clinical studies are changing for the better,” said F. Marc Stewart, MD, medical director at Seattle Cancer Care Alliance (SCCA). “Many of our studies use approaches that previously might have been limited to younger patients but that now, due to research advances, are very appropriate for older people.”

Decisions about treatment are personal. No matter what your age, if you have cancer or another serious disease, you should consider all available treatment options, including clinical studies. Ask your SCCA treatment team about the risks, benefits, and goals of each treatment option to decide which is best for you. You may find that a clinical study is the right decision.

Why It’s Important for Older Adults to Join Clinical Studies

Worldwide, the population of older adults is increasing. Since the greatest risk factor for cancer is age, it is no surprise that the majority of new cancer cases and cancer-related deaths are in people over age 65. This is also why experts predict the number of older cancer patients and survivors seeking treatment will increase exponentially in the future.

Studies of many different cancers have demonstrated that age may be a factor in the tendency for cancer to spread, and older patients may need to take different dosages of medications and may experience different side effects than younger patients. Since the course of cancer and the effects of treatment may be different in older people, studies that involve older people with cancer are needed to find the best interventions for this growing population.

Participation by Older Adults Now

Despite this need, few older people participate in clinical studies. As recently as the mid-1990s, less than one in four clinical study participants was 65 years old or older; yet this same age group made up almost two-thirds of new cancer diagnoses and nearly three-quarters of cancer-related deaths.

There are many reasons why more older adults don’t participate in clinical studies, including:

  • The standard treatment, not a clinical study, may be the best option for them.
  • Older patients are less likely to be offered a clinical study.
  • Medical histories and conditions common in older patients—such as diabetes, high blood pressure, heart disease, lung disease, kidney disease, arthritis, or dementia—can affect compliance and survival, and make analysis of study results more difficult.
  • Older patients and their doctors may be concerned about the potential side effects of an investigational intervention.
  • Exclusion criteria for studies—such as advanced age, reduced life expectancy, physical disabilities, illnesses, and functional limitations—disproportionately affect older patients.

Other factors that tend to decrease the number of older patients in studies include preference for treatment from their community doctor (who is less likely to offer studies), difficulty getting to health care centers where studies take place, additional time required for enrollment and follow-up, and costs of care.

Certainly studies in older populations are complicated by these factors, but with modifications more clinical studies could be appropriate for older adults. For example, studies could evaluate outcomes that are more relevant to older adults, such as how their quality of life is affected (like how long they go without symptoms or how toxic the treatment is for them), instead of how long it takes for their disease to progress.

Even though older patients have been underrepresented in clinical studies in the past, this is starting to change. In the United States, the increase may be due to expanding Medicare coverage for studies. In addition, as reported by the American Society of Clinical Oncology in 2013, three-fourths of patients over 70 said they would be willing to take part in a study, so perhaps more patients and their doctors are considering studies as an option.

Learn More

Whatever your age, consider clinical studies. Ask your doctor whether you qualify for any studies and whether any of them might be a good option for you. For more information, be sure to read the rest of this patient guide to clinical studies. Also, there are several other websites where you can learn more, including websites specific to older adults.